[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37058-37062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 797]


FY 1997; Studies To Evaluate the Epidemiologic and Laboratory 
Characteristics of Human Immunodeficiency Virus (HIV) Infection Among 
United States Blood and Plasma Donors

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for cooperative agreements 
to provide assistance for epidemiologic surveillance studies of human 
immunodeficiency virus (HIV) in U.S. blood and plasma donors. These 
studies will be conducted to describe the epidemiology of human 
immunodeficiency virus (HIV), other retroviruses, and related 
conditions in persons whose blood tests positive for HIV antibody, HIV 
antigen, or other related laboratory markers. Additional funds will be 
available for laboratory studies of the genetic variation of HIV among 
blood and plasma donors and other selected populations.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of HIV Infection. (For 
ordering a copy of ``Healthy People 2000,'' see the Section WHERE TO 
OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under Sections 301(a) and 317(k)(2) of 
the Public Health Service Act (42 U.S.C. 241(a) and 247b(k)(2)), as 
amended. Applicable program regulations are set forth in 42 CFR Part 
52, entitled ``Grants for Research Projects.''

Smoke-Free Workplace

    CDC strongly encourages all cooperative agreement recipients to 
provide a smoke-free workplace and promote the non-use of all tobacco 
products. Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities that receive Federal funds in which 
education, library, day care, health care, and early childhood 
development services are provided to children.

Eligible Applicants

    Eligible applicants include all nonprofit and for-profit blood 
centers and organizations and governments and their agencies. Thus, 
universities, colleges, research institutions, hospitals, and other 
public and private organizations, State and local health departments or 
their bona fide agents or instrumentalities, federally recognized 
Indian tribal governments, Indian tribes or Indian tribal 
organizations, and small, minority- or women-owned businesses are 
eligible to apply.

    Note: Organizations described in section 501(c)(4) of the 
Internal Revenue Code of 1986 that engage in lobbying are not 
eligible to receive Federal grant/cooperative agreement funds.

Availability of Funds

    Approximately $1,200,000 will be available in FY 1997 to fund 
approximately 5-10 awards. It is expected that the average award will 
be approximately $200,000, with a range from $20,000 to $800,000. It is 
expected that approximately 2 new and 6 competing renewal awards will 
be made and that awards will begin on or about September 30, 1997. 
Awards will be funded for a 12-month budget period within a project 
period of up to 5 years. Funding estimates may vary and are subject to 
change.
    Continuation awards within the project period will be made on the 
basis of satisfactory programmatic progress and the availability of 
funds.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of Department 
of Health and Human Services (HHS) funds for lobbying of Federal or 
State legislative bodies. Under the provisions of 31 U.S.C. Section 
1352 (which has been in effect since December 23, 1989), recipients 
(and their subtier contractors) are prohibited from using appropriated 
Federal funds (other than profits from a Federal contract) for lobbying 
Congress or any Federal agency in connection with the award of a 
particular contract, grant, cooperative agreement, or loan. This 
includes grants/cooperative agreements that, in whole or in part, 
involve conferences for which Federal funds cannot be used directly or 
indirectly to encourage participants to lobby or to instruct 
participants on how to lobby.
    In addition, the FY 1997 Departments of Labor, HHS, and Education, 
and Related Agencies Appropriations Act, which became effective October 
1, 1996, expressly prohibits the use of 1997

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appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. Section 503 of this new law, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Public Law No. 104-208 (September 30, 1996), provides as 
follows:

    Sec. 503(a) No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress, * * * 
except in presentation to the Congress or any State legislative body 
itself.
    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract 
recipient, or agent acting for such recipient, related to any 
activity designed to influence legislation or appropriations pending 
before the Congress or any State legislature.

Background

    In the United States, about 8 million people donate approximately 
14 million units of whole blood each year; donors also give about 12 
million units of plasma for use in making immune globulin, clotting 
factors, and other products. During the last decade, improved donor 
screening and education and better laboratory tests for blood-borne 
viruses have markedly increased the safety of the nation's blood 
supply.
    The Centers for Disease Control and Prevention has monitored data 
from the routine testing of blood donors since the first HIV antibody 
screening test was licensed in 1985. Since 1988, CDC has collaborated 
with the National American Red Cross and other major blood collection 
agencies to systematically evaluate the characteristics of HIV-infected 
donors through detailed interviews and follow-up. From 1988 to 1995, 
the seroprevalence of HIV among blood donors decreased threefold, from 
approximately 1 in 4,000 to 1 in 12,000 donors. This decrease was due 
in part to the elimination of seropositive donors from the repeat donor 
pool. However, HIV seroprevalence among first-time donors has also 
declined. Because persons with known risks for HIV infection are 
actively discouraged from donating, information about HIV-infected 
donors identified during the screening process is valuable for further 
improving donor deferral procedures and may offer clues to emerging 
patterns of HIV transmission.
    Current estimates of the residual risk of HIV transmission from 
blood transfusion are based on mathematical models; these models 
require estimates of the incidence of HIV infection among blood donors 
and the length of the infectious window period. A recent analysis 
suggested that there was a risk of 1 case of HIV transmission for every 
450,000 to 660,000 donations of screened blood. This estimate is much 
smaller than earlier estimates, principally because of the improved 
sensitivity of enzyme immunoassay screening tests for HIV antibody. The 
ability to monitor the risk of HIV transmission by blood transfusion 
depends on methods for maintaining surveillance of incident HIV 
infection among blood donors and characterizing the infectious window 
period.
    Since March 1996, donated blood has also been screened for HIV p24 
antigen. On average, p24 antigen tests become positive approximately 6 
days before enzyme immunoassays for HIV antibody. Surveillance 
conducted by CDC, the National American Red Cross, and other blood 
collection agencies suggest that p24 antigen screening has thus far 
done little to improve blood safety; however, it has raised issues 
concerning counseling and exclusion of donors who have false positive 
test results and donors who may seek testing by a more sensitive test 
than is routinely offered. In addition, concerns have been raised over 
the presence of HIV strains poorly detected by commonly used screening 
assays (e.g., group O). As testing technology continues to evolve, 
blood donation provides a critical setting for evaluating the 
performance characteristics of existing and new screening techniques, 
as well as their potential impact on blood safety.
    Although incidence and prevalence of HIV infection are lower among 
blood donors than among unselected populations, the routine screening 
of very large numbers of repeat blood donors identifies substantial 
numbers of persons with recently acquired HIV infection. A newly 
developed, ``detuned'' enzyme immunoassay can identify HIV infections 
acquired during a relatively recent interval among first-time, as well 
as repeat, donors and among other significant populations. Defining the 
epidemiologic and laboratory characteristics of these recently infected 
persons is important for understanding the evolution of the HIV 
epidemic in the U.S. For example, HIV genomes from such persons are 
needed for larger studies of subtype variation and primary drug 
resistance.

Purpose

    The purpose of these awards is to support research for 
epidemiologic surveillance studies to gain a greater understanding of 
the HIV epidemic and the safety of the U.S. blood supply. In 
particular, studies with flexibility to support surveillance of other 
transfusion-transmissible agents in addition to HIV will be considered.

I. Surveillance and Interview Studies of Blood and Plasma Donor 
Populations

    A. Monitor the prevalence and incidence of HIV infection in blood 
and plasma donors at selected centers throughout the U.S. and Puerto 
Rico.
    B. Analyze the demographic, behavioral, and laboratory 
characteristics of HIV-infected and non-infected donors to strengthen 
the effectiveness of donor screening and deferral processes.
    C. Estimate the risk of HIV transmission from screened blood and 
plasma.
    D. Identify persons and characteristics of persons recently 
infected with HIV.

II. Laboratory Studies of Blood and Plasma Donors and Other Significant 
Populations

    A. Evaluate the effectiveness of screening blood donations for HIV-
1 p24 antigen.
    B. Evaluate the performance of proposed or potential HIV screening 
tests (e.g., amp-RT and viral RNA assays).
    C. Describe the evolution of laboratory markers during the interval 
between acquisition of HIV infection and seroconversion (including the 
``window period'').
    D. Conduct molecular epidemiologic studies of HIV and related 
viruses in blood and plasma donors and other populations of 
epidemiologic significance. These studies could include surveillance 
for non-B HIV subtypes, primary antiretroviral drug resistance, and 
segregation of viral strains according to demographic and behavioral 
risk characteristics.
    Applications should indicate whether they are addressing research 
issues identified under sections I. or II. above, or both. Applications 
for sections I. and II. will be evaluated separately.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities listed under A. 
(Recipient Activities), and CDC shall be responsible for conducting 
activities listed under B. (CDC Activities). The applications should be 
presented in a manner that

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demonstrates the applicant's ability to address the proposed activities 
in a collaborative manner with CDC.

A. Recipient Activities

    1. Develop research study protocols, consent forms, questionnaires, 
and data collection methods.
    2. Identify, recruit, obtain informed consent from, and enroll an 
adequate number of study participants as determined by study protocols 
and program requirements.
    3. Conduct epidemiologic studies at specified sites using approved 
study protocols established through the recipient's participation with 
CDC and other collaborating institutions.
    4. Perform selected laboratory tests according to established 
research protocols. Store all HIV seropositive sera and additional 
specimens (sera or cells) as may be required by the research study 
designs.
    5. Participate in the development and maintenance of data 
management systems for the study.
    6. Share data and specimens with other collaborators when 
appropriate to answer specific research questions.
    7. Analyze study data and present findings in scientific 
presentations and publications.

B. CDC Activities

    1. Provide technical assistance in the design and conduct of the 
research.
    2. Provide technical guidance in the development of study 
protocols, consent forms and questionnaires, including training and 
pretesting as necessary.
    3. Assist in designing a data management system. As requested, 
carry out central data management functions.
    4. As requested, perform selected laboratory tests.
    5. Provide specimens for selected laboratory studies.
    6. Facilitate collaboration among the different sites including 
laboratories and consultants.
    7. Collaborate with recipients in the analysis of research 
information and the presentation of research findings.

Technical Reporting Requirements

    1. An original and two copies of annual progress reports are 
required no later than 90 days after the end of the budget period. The 
annual reports for current awardees will be submitted with the renewal 
application.
    2. Final financial status and performance report is also required 
no later than 90 days after the end of the project period. All reports 
are submitted to the Grants Management Branch, Procurement and Grants 
Office, CDC.

Application Content

    Applications must be developed in accordance with PHS Form 5161-1 
and the instructions outlined under the following section headings. The 
application should provide a detailed description of first-year 
activities and only briefly describe future-year activities. To assist 
in evaluating the application, please limit the number of pages to 25 
plus attachments.
A. Executive Summary
B. Table of Contents
C. Background and Needs
    1. Demographic and geographic characteristics of the proposed study 
population.
    2. Reported cases of AIDS and/or HIV infection, patterns of 
behavioral risk correlated illnesses (e.g., syphilis, hepatitis, etc.) 
in the study population.
    3. Previous efforts to conduct similar studies and uses of the 
resulting data.
D. Capacity
    1. Demonstrated knowledge, ability and resources to conduct 
epidemiologic or laboratory studies.
    2. Ability to enroll and evaluate adequate numbers of eligible 
study participants or to obtain and examine appropriate numbers and 
types of laboratory specimens.
    3. Position descriptions for all key project personnel. These may 
be included in the appendix but should be referenced in the text.
E. Goals and Objectives
    1. List one or more goals for the project.
    2. List specific measurable outcome objectives related to program 
development and implementation; training and data quality; data 
analysis and dissemination, including potential plans for linkage with 
other data systems; and program evaluation.
F. Methods/Activities
    1. Describe activities related to each objective.
    2. Specify timelines for completing each activity.
    3. Designate personnel resources and assignments to specific 
project activities.
G. Project Evaluation
    1. Evaluation plan should contain specific activities to collect 
data to measure program development and implementation.
    2. Describe how information will be obtained, prepared in specific 
reports, and used to improve the program.
H. Budget
    1. Line-item descriptive justification for personnel, travel, 
supplies and other services should be submitted. Applicant should be 
precise about the purpose of each budget item as it relates to the 
project.
    2. If applicable, applicants requesting funding for contracts 
should include the name of the person or firm to receive the contract, 
the method of selection, the period of performance, and a description 
of the contracted service requested.
    3. Funding levels for years two and through five should be 
estimated.
I. Supporting Materials
    1. Curriculum vitae and job descriptions of critical staff.
    2. Letters of endorsement and/or collaboration of participating 
centers, agencies and/or State or local public health departments.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria:
    1. The applicant demonstrates the knowledge, ability and resources 
to conduct epidemiologic or laboratory studies of HIV and related 
viruses in U.S. blood and plasma donors or other populations of 
epidemiologic significance. (30 points)
    2. The applicant demonstrates the ability to enroll and evaluate 
adequate numbers of eligible study participants (e.g., HIV-seropositive 
donors) or to obtain and examine appropriate numbers and types of 
laboratory specimens. (25 points)
    3. The applicant presents a sound plan for conducting and 
evaluating program activities. If tests of clinical significance are 
performed, the application should include a plan for notifying study 
subjects. (15 points)
    4. The applicant proposes objectives that are measurable, specific, 
time-phased, and related to required recipient activities and program 
purpose. (10 points).
    5. The applicant demonstrates willingness to cooperate in a study 
with CDC and other collaborating institutions. (10 points)
    6. The size, qualifications, and time allocation of the proposed 
staff and the availability of facilities are adequate for the study. 
(10 points)
    7. The budget is reasonable, clearly justified, consistent with the 
intended use of funds, and allowable. All budget categories should be 
itemized. (Not scored)
    8. Procedures are adequate for the protection of human subjects, 
whether

[[Page 37061]]

or not exempt from the Department of Health and Human Services (DHHS) 
regulations. (Not scored) Recommendations on the adequacy of 
protections include: (a) Protections appear adequate and there are no 
comments to make or concerns to raise; (b) protections appear adequate, 
but there are comments regarding the protocol; (c) protections appear 
inadequate and the Objective Review Group (ORG) has concerns related to 
human subjects; or (d) disapproval of the application is recommended 
because the research risks are sufficiently serious and protection 
against the risks are inadequate as to make the entire application 
unacceptable.

Funding Priority

    Priority will be given to competing continuation applications from 
satisfactorily performing projects over applications for projects not 
already receiving support under the program. Projects will be awarded 
so that the composite of projects reflects the geographic and 
demographic distribution of the study population.

Executive Order 12372 Review

    Applications are not subject to review under Executive Order 12372, 
Intergovernmental Review of Federal Programs.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.944, Human 
Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Virus Syndrome 
(AIDS) Surveillance.

Other Requirements

1. Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

2. Human Subjects

    This program involves research on human subjects. Therefore, all 
applicants must comply with the Department of Health and Human Services 
Regulations, 45 CFR part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project or 
activity will be subject to initial and continuing review by an 
appropriate institutional review committee. The applicant will be 
responsible for providing assurance in accordance with the appropriate 
guidelines and form provided in the application kit.
    In addition to other applicable committees, Indian Health Service 
(IHS) institutional review committees also must review the project if 
any component of IHS will be involved with or support the research. If 
any American Indian community is involved, its tribal government must 
also approve that portion of the project applicable to it.

3. HIV Program Review Panel

    Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires, 
Survey Instruments, and Educational Sessions (June 1992) (a copy is in 
the application kit). To meet the requirements for a program review 
panel, recipients are encouraged to use an existing program review 
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review 
panel, at least one member must be an employee (or a designated 
representative) of a State or local health department. The names of the 
review panel members must be listed on the Assurance of Compliance form 
CDC 0.1113, which is also included in the application kit. The 
recipient must submit the program review panel's report that indicates 
all materials have been reviewed and approved.

4. Patient Care

    Applicants should provide assurance that all HIV-infected patients 
enrolled in their studies will be linked to an appropriate local HIV 
care system that can address their specific needs such as medical care, 
counseling, social services, and therapy. Details of the HIV care 
system should be provided, describing how patients will be linked to 
the system. Funds will not be made available to support the provision 
of direct care for study participants.

5. Women, Racial and Ethnic Minorities

    It is the policy of the CDC to ensure that individuals of both 
sexes and the various racial and ethnic groups will be included in CDC-
supported research projects involving human subjects, whenever feasible 
and appropriate. Racial and ethnic groups are those defined in OMB 
Directive No. 15 and include American Indian, Alaskan Native, Asian, 
Pacific Islander, Black and Hispanic. Applicants shall ensure that 
women, racial and ethnic minority populations are appropriately 
represented in applications for research involving human subjects. 
Where clear and compelling rationale exist that inclusion is 
inappropriate or not feasible, this situation must be explained as part 
of the application. This policy does not apply to research studies when 
the investigator cannot control the race, ethnicity and/or sex of 
subjects. Further guidance to this policy is contained in the Federal 
Register, Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-
47951 (a copy is included in the application kit).

6. Confidentiality

    Recipients must describe confidentiality and security provisions to 
protect data collected through HIV/AIDS surveillance, including copies 
of local data release policies; employee training in confidentiality 
provisions; State laws, rules, or regulations pertaining to the 
protection or release of surveillance information; and physical 
security of hard copies and electronic files containing confidential 
surveillance information. Recipients must describe any laws, rules, 
regulations, or health department policies that require or permit the 
release of patient identifying information collected under the HIV/AIDS 
surveillance system to entities outside of the public health department 
and measures the health department has taken to ensure that the 
confidentiality of individuals reported to the surveillance system is 
protected from further or unlawful disclosure.

Application Submission and Deadline

    The original and two copies of the application PHS Form 5161-1 (OMB 
Number 0937-0189) must be submitted to Van Malone, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mail Stop E-15, Atlanta, Georgia 30305 on or 
before August 11, 1997.

1. Deadline

    Applications shall be considered as meeting the deadline if they 
are either:
    A. Received on or before the stated deadline date; or
    B. Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall

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not be accepted as proof of timely mailing.)

2. Late Applications

    Applications that do not meet the criteria in 1.A. or 1.B. above 
are considered late applications. Late applications will not be 
considered in the current competition and will be returned to the 
applicant.

Where To Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Van Malone, Grants Management Officer, 
Grants Management Branch, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., 
Room 300, Mail Stop E-15, Atlanta, Georgia 30305, telephone (404) 842-
6575, Email address [email protected]. The announcement will be available on 
one of two Internet sites on the publication date: CDC's home page at 
http://www.cdc.gov, or at the Government Printing Office home page 
(including free access to the Federal Register) at http://
www.access.gpo.gov.
    Programmatic technical assistance may be obtained from Dr. Richard 
Steketee or Dr. Marta Gwinn, Division of HIV/AIDS Prevention, National 
Center for HIV, STD, TB Prevention, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mail Stop E-46, Atlanta, 
Georgia 30333, telephone (404) 639-2090. Eligible applicants are 
encouraged to call before developing and submitting their application. 
Please refer to Announcement Number 797 when requesting information.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report: Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report: Stock No. 017-001-00473-1) referenced in the 
Introduction from the Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: July 3, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-18062 Filed 7-9-97; 8:45 am]
BILLING CODE 4163-18-P